Clinical, Service, and Cost Outcomes of Computerized Prescription Order Entry

a pharmacist-directed clinic could embrace “brown-bag” medication reviews and provide comprehensive evaluation of the complete drug therapy of a given patient to identify opport u n i t i e s for generic substitution, therapeutic interchange, or discontinuation of unnecessary drug therapy. The pharmacist-directed clinic could also contribute to positive drug therapy outcomes by encouraging compliance and continuation of medically necessary drugs. At the PRICE Clinic, 215 patients (41%) were at risk for drug discontinuation due to cost, and 186 (87%) of these at-risk patients were able to continue the drugs (74% attributed to PAP versus 20% associated nearly equally with either generic drug substitution or therapeutic interchange). The favorable outcomes of the PRICE Clinic would appear large in the context of the estimated annual operating cost of about $60 per patient, including significant contributions from volunteers and students. A recent survey of 519 cardiologists and general internists suggests that physicians welcome pharmacist-directed PAPs. The survey found that the most common barriers to physician communication with patients about the cost of medications were lack of habit, insufficient time, and concern over patient discomfort. The most common strategies that physicians used to assist patients were switching to a generic drug, using office samples, and discontinuing nonessential medicines. There were no statistically significant differences between cardiologists and general internists in barriers or strategies examined, and the researchers concluded that patient-physician communication about out-of-pocket costs is a problem affecting specialists and generalists nationwide.


■ ■ Clinical, Service, and Cost Outcomes of Computerized Prescription Order Entry
Brent James, MD, has become a self-proclaimed "terrorist" for health care safety. His philosophy is that a revolutionary attitude is necessary since too many patients are being harmed in the health care system due to the absence of energetic, focused, and sustained attention to system processes that contribute to medical errors. As the director of the Institute for Healthcare D e l i v e ry Research at Intermountain Health Care, James has the o p p o rtunity to influence health system outcomes in Utah. T h rough the Institute' s Advanced Training Program in continuous quality improvement, this terrorist for health care safety also influences health care delivery throughout the United States.
Drs. Stryer and Clancy from the Center for Quality Improvement and Patients Safety, U.S. Agency for Healthcare Research and Quality (AHRQ) lend support to the crusade by Dr. James in their distillation of the evidence for shortfalls in patient safety-the absence of a culture of safety in health care. 11 They observe that a culture of safety has the greatest potential to produce sustainable improvements in safety and cite the National Patient Safety Agency and the National Quality Forum as advocates for a culture of safety as a top priority for a safer health care system. James puts this notion into action by re c i t i n g to the health system board of directors the names of patients who experienced potentially avoidable death. This is part of what he means by terrorism for health care safety. Drs. Stryer and Clancy point readers to a Web site (Web M&M-Morbidity and mortality rounds on the Web) that shows 5 reported cases of avoidable patient harm plus statistics such as the high p e rcentage (more than 75% for physicians and more than 50% for nurses and other caregivers) who re p o rt that (a) "some coworkers repeatedly take shortcuts that could endanger patients" and that they (b) "work with some people who show poor clinical judgment." 12 It would be wonderful if technology could come to our rescue and make the job of protecting patient safety easier. We would all like a system solution that is good, fast, and cheap. We might even embrace a solution for safety that has 2 out of 3 of these measures. Unfortunately, the experience suggests that information technology solutions such as computerized prescription order entry (CPOE) are not fast or cheap and may not be all that good either. The truth probably lies in the details.
Thankfully, there are some skeptical enough to study the advantages and shortcomings of CPOE and clinical decision supports systems (CDSSs). While the widespread adoption and ubiquitous use of these electronic tools are inevitable, it appears that much work remains to be done in refining these tools and the process of care. Koppel et al. studied house staff interaction with a CPOE system at a tert i a ry -c a re teaching hospital (2002)(2003)(2004), including in-depth interviews with pharmacy leaders, attending physicians, nurses, and information technology leaders and survey responses from 261 (88%) CPOE users. 13 The research uncovered 22 types of medication error risks that were facilitated by the CPOE system, including separation of functions that facilitate double dosing and incompatible orders and inflexible ordering formats that generate wrong orders. The researchers concluded that each of these 22 error risks occurred weekly or more often.
CPOE is a subset of computer entry systems that are used in the laboratory, in pharmacy, and by nurses and others involved in patient care. The Web-based MedMARx database of the United States Pharmacopeial Convention (USP) contained 27,711 reports of computer-entry errors in 2003, accounting for 13% of the medication errors (ME) re p o rted in 2003 by 570 health care facilities, including hospitals and outpatient care centers. Computer-entry errors were the seventh leading case of errors in 1999, rising to fourth place in 2003. Less than 1% (0.74%) of computer-entry errors resulted in actual harm to the patient, and 71% of the errors were "intercepted" before reaching the patient. These data suggest that computerization does not eliminate MEs, caused, for example, by misunderstanding the intent of abbreviations in computerized orders. 14 However, the good news in the USP data is an apparent favorable effect of information technology (IT) on patient harm-while 1.5% of all MEs resulted in patient harm, 0.7% of errors involving computer entry resulted in patient harm and only 0.1% of CPOE errors resulted in patient harm. 15 Anecdotes of IT errors also help to emphasize the point that IT offers tools to help protect patient safety, but oversight and learning from mistakes are still necessary. A pharmacy manager reported in early July 2004 that their pharmacy team averted a potential medication error that was caused by a physician using their CPOE system. A visiting pediatrician had intended to ord e r gentamicin ophthalmic with the instru c t i o n s "use as directed." Instead, the prescriber hit the wrong key, ordering gentian violet topical. 16 CPOE has the potential to eliminate the errors due to poor handwriting, but CPOE introduces the potential for new types of errors.
Setting aside the criteria of good, fast, and cheap, there is mounting evidence that CPOE and CDSS can have a favorable effect on clinical and service outcomes. A systematic review published in March 2005 of articles referenced in MEDLINE, EMBASE, Cochrane Library, Inspec, and ISI databases and consulting reference lists through September 2004 identified 97 randomized and nonrandomized controlled trials that evaluated the effect of a CDSS compared with care provided without a CDSS on practitioner perf o rmance or patient outcomes. 17 In their evaluation of methods, setting, CDSS and patient characteristics, and outcomes, Garg et al. contacted the authors of 64 primary studies to confirm data or provide additional information. Most of the studies (64%) assessed practitioner performance, and only 52 (54%) trials assessed one or more patient outcomes. Of all 97 studies, only 7 trials (7%) reported improvements in patient outcomes, or 13% of the CDSS evaluations that included assessment of patient outcomes.
Kawamoto et al. evaluated 70 studies that met their criteria for systematic review according to 15 features of CDSS reported in the literature as important to significant clinical practice i m p ro v e m e n t . 1 8 Decision support systems significantly impro v e d clinical practice in 68% of trials. Five of the 15 CDSS features were found to be important according to univariate analyses. Analysis by multiple logistic regression narrowed the list to 4 features that were independent predictors of improved clinical practice: automatic provision of decision support as part of clinician workflow (P < 0.001), provision of recommendations rather than just assessments (P = 0.019), provision of decision support at the time and location of decision making (P= 0.026), and computer-based decision support (P = 0.0294). Of the 32 C D S S s that possessed all 4 features, 30 (94%) significantly improved clinical practice.
Among the many interventions designed to reduce the gap between practice guidelines and actual clinical practice, Grol and Grimshaw concluded that reminders that appear when physicians are writing prescriptions represent one of the most effective means to influence physician behavior. 19 Durieux observed, however, that the literature reflects greater research interest in physician behavior than in patient outcomes. 20 Yet, there are encouraging results from interventions that remind physicians at the point of care about patient risk factors that might suggest a particular physician behavior. For example, 2,506 patients at risk of venous thromboembolism (VTE) but who did not receive VTE prophylaxis were assigned to either a control group or an intervention group in which a CDSS calculated the VTE risk profile from 8 common risk factors for each h o s p i t a l i z e d patient. Measured at 90 days of observation, there were 61 patients (4.9%) in the intervention group versus 103 patients (8.2%) in the control group who experienced either deep-vein thrombosis or pulmonary embolism, a relative risk reduction of 41% (hazard ratio 0.59; 95% confidence interval, 0.43 to 0.81). 21 While there is little evidence of the value of CDSS compared with the research results on physician behavior, there is even less evidence that these tools can have a favorable effect on cost outcomes. In this issue of JMCP, McMullin, Lonergan, and Rynearson found that 19 clinicians (16 physicians, 2 nurse practitioners, and 1 physician assistant) had average pre s c r i p t i o n costs for new prescriptions that were $4.78 (10.5%) less than projected based upon the average prescription cost in the control group; after correcting for patient clustering, the savings were calculated to be $4.12 (9.0%) per new prescription. 22 Based on this difference, the total 12-month savings on new p rescriptions were $109,897, or an average of $482 per prescriber per month. For all prescriptions, the average drug cost savings per prescriber per month were found to be $863 or $873, depending on the method of analysis, overwhelming the monthly subscription price for the CDSS/CPOE and producing net savings of more than $700 per prescriber per month. Drug cost savings were $0.57 (8.8%) per member per month (PMPM) for new prescriptions and $1.07 (5.4%) for all prescriptions. The CDSS/CPOE was also found to reduce the proportion of prescriptions for high-cost drugs that were the target of the CDSS messages to prescribers, a relative 17.5% lower among the intervention group (35.8%) compared with the control group (43.4%) (P = 0.03).
Two additional points warrant notice in this study. Drug cost PMPM could have been influenced by the imbalance in the ratio of internal medicine physicians in the intervention group (19%) compared with the control group (44%). The higher ratio of internists in the control group no doubt contributed to the 11.5% higher average utilization in the control group in the baseline period (0.426 prescriptions PMPM versus 0.382), a difference that continued through the observation period (11.7% higher utilization, 0.460 prescriptions PMPM for the control group versus 0.412 for the CDSS intervention group). This does not appear to directly influence either of the 2 principal measures of this study, the average price per prescription or the ratio of high-cost drugs to total drugs in the 8 therapeutic class targets, but an avoidable variable was introduced by this i m p o rtant diff e rence in physician specialty between the 2 groups. Second, the CDSS described by McMullin et al. appears to be associated with a favorable re t u rn on investment as measured by drug cost, with the savings derived from lower price not lower utilization. In other words, savings were derived from lower-cost drugs not fewer drugs. There are however, no specific measures of clinical outcomes in this s t u d y, and the literature, in general, remains inadequate re g a rd i n g information on the effects of CDSS on clinical outcomes.

■ ■ Value for Money in Disease Management of Acute Coronary Syndrome-The Price of Aspirin to Reduce the Costs of ACS
Cost per outcome is an important measure. The Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction (PROVE IT-TIMI) 22 clinical trial showed that aggressive treatment with atrovastatin, to an average low-density lipoprotein (LDL) cholesterol level of 62 mg/dL, was associated with improved clinical outcomes in patients with ACS (unstable angina or post-MI). Pravastatin 40 mg per day was found to be associated with a combined 26.3% incidence of death, MI, or worsening cardiac complications versus 22.4% with atorvastatin 80 mg per day, a 16% relative diff e re n c e . There was a 28% relative difference in deaths among these ACS patients, 3.2% on pravastatin versus 2.2% for atorvastatin. The difference was not statistically significant but was reported as clinically significant when the results were released at a meeting of the American College of Cardiology in New Orleans on March 8, 2004. 23 The 3.9% absolute difference in the composite end point in PROVE IT-TIMI 22 translated into a 16% reduction in the hazard ratio in favor of atorvastatin (P = 0.005). The 3.9% absolute diff e rence also translated into the need to treat 25.6 patients for 2 years with 80 mg atorvastatin per day to prevent 1 death, or nonfatal MI, or cardiac complication, compared with pravastatin 40 mg per day. 24 Treating 25.6 ACS patients for 2 years with atorvastatin 80 mg per day would incur $57,372 in discounted atorvastatin drug cost in April 2005 dollars. 25 On the other hand, atorvastatin 80 mg per day has a discounted drug cost in 2005 of $2,311 per patient tre a t e d for 2 years, 26% less than the $2,920 per patient treated for